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市場調查報告書
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1539235

全球製藥和生物技術產業的臨床前合作夥伴條款和協議(2019-2024)

Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019-2024

出版日期: | 出版商: Current Partnering | 英文 1500+ Pages | 商品交期: 最快1-2個工作天內

價格

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簡介目錄

本報告詳細了解並分析了公司如何、為何以及在什麼條件下進行臨床前合作。這些交易往往是跨部門的,從合作研發開始,一直延伸到成果的商業化。

本報告詳細介紹了醫療領域宣布的最新臨床前協議。

了解潛在合作夥伴談判的交易條款的靈活性有助於深入了解談判過程,了解條款談判期間的預期結果。雖然許多小型企業想要詳細的付款條款,但付款方式的問題在於細節。合約文件提供了新聞稿或資料庫中沒有的見解。

這份報告包含了自2019年以來宣布的所有臨床前階段合作的完整列表,並包括交易各方披露的實際臨床前合作的線上交易記錄,還包括超過 3,900個鏈接。此外,如果有的話,會記錄公司及其附屬公司向美國證券交易委員會提交的合約文件。

本報告包​​括數百家生命科學公司宣布的交易,包括Takeda, AstraZeneca, Eli Lilly, Sanofi, Boehringer Ingelheim, Merck, Roche, Bristol-Myers Squibb, Astellas等主要製藥公司。

本報告也包括一些圖表,顯示自2019年以來與臨床前合作夥伴關係和交易相關的趨勢和活動。

此外,還提供了自2019年以來所有發現的綜合附錄,按合作夥伴名稱(A-Z)、病例類型、治療重點領域和技術類型進行組織。每筆交易的標題都透過網路連結連結到交易記錄的線上版本,並在可用的情況下連結到合約文件,以便在需要時輕鬆存取每個合約文件。

總而言之,本報告提供了潛在交易者需要了解的有關臨床前產品和化合物的研發和商業化合作的所有資訊。

主要優點

本報告為讀者提供了以下主要好處:

  • 有關臨床前階段合約趨勢的詳細資訊(自2019年起)
  • 存取交易總額、預付款、里程碑和忠誠度資料
  • 使用大量真實案例研究來分析臨床前合約結構
  • 實踐中的範例條款以及對臨床前合約中包含的條款的深入了解
  • 公司在過往交易中商定的主要交易條款的識別
  • 進行實質審查:評估向合作夥伴公司提出的合約條款的適用性

調查範圍

  • 本報告目的是讓讀者深入了解和了解全球領先公司簽訂的臨床前階段協議的趨勢和結構。

本報告提供的資訊:

  • 生物製藥產業臨床前階段交易趨勢(2019年起)
  • 臨床前階段交易結構分析
  • 存取交易總額、預付款、里程碑和忠誠度資料
  • 實際臨床前階段專案案例研究
  • 參與臨床前階段計畫(超過 2,900個)
  • 臨床前階段的主要案件(依據金額,2019年起)
  • 臨床前階段最活躍的交易撮合者(2019年起)
  • 臨床前階段的主要聯盟(2019)

此報告列出了可用合約的以下資訊:

  • 公司名稱(A-Z)
  • 總交易金額
  • 合約簽訂時的開發階段
  • 合約類型
  • 具體治療標靶
  • 每筆交易的標題都透過網路連結連結到交易記錄的線上版本以及合約文件(如果有),可以輕鬆按需存取每份合約文件。

此報告提供了對 1,800 多個臨床前階段交易的可用交易和合約文件的全面存取。分析實際合約協議能夠評估:

  • 授予或選擇的具體權利是什麼?
  • 合約實際上授予合作夥伴公司什麼?
  • 授予哪些類型的專有權?
  • 合約的付款結構是怎樣的?
  • 如何審核銷售和付款?
  • 條款和條件是什麼?
  • 合約的主要條款是如何定義的?
  • 智慧財產權的處理和所有權如何?
  • 誰負責商業化?
  • 誰負責開發、供應和製造?
  • 如何管理保密和發布?
  • 如何解決爭議?
  • 什麼情況下可以取消合約?
  • 如果所有者發生變化會怎樣?
  • 已就何種類型的分授權或分包條款達成協議?
  • 公司主張哪些樣板條款?
  • 哪些樣板條款會根據合作夥伴和交易類型的不同而有所不同?
  • 公司對契約法主張哪一個管轄權?

目錄

執行摘要

第1章 簡介

第2章 為什麼公司在臨床前階段合作

  • 簡介
  • 合作關係在臨床前階段的作用
    • 臨床前階段的許可引進
    • 臨床前階段的許可
  • 藥物發現、臨床前和臨床階段交易的差異
  • 在臨床前階段簽訂合作協議的原因
    • 授權人(授權人)為何在臨床前階段簽訂協議
    • 為什麼被許可人(被許可人)在臨床前階段簽訂合約
  • 臨床前合作交易的未來

第3章 臨床前階段交易策略與結構

  • 簡介
  • 公司在什麼階段結盟?
    • 製藥/生技領域的早期合作
    • 製藥/生技領域的後期合作
  • 早期與後期聯盟:比較風險/成本
  • 公司在臨床前合作上花了多少錢?
  • 純/複合組件合作協議
  • 純粹授權協議的結構
    • 臨床前階段純許可協議範例
    • a.個案研究(9)
    • b.個案研究(10)
  • 臨床前階段多成分合作協議
    • 多成分/臨床前條款範例
    • a.個案研究(11)
    • b.個案研究(12)

第4章 臨床前階段聯盟的支付策略

  • 簡介
  • 臨床前付款策略
  • 付款方式
    • 總交易金額
    • 預付款
    • 貸款
    • 可轉換貸款
    • 股權
    • 研發資金
    • 許可費
    • 里程碑付款
    • 特許權使用費
    • QUIDS
    • Option payments

第5章 臨床前階段交易趨勢

  • 簡介
  • 最近的臨床前階段聯盟
    • 臨床前交易的屬性
  • 臨床前合作夥伴關係:依交易類型
  • 臨床前階段的合作關係:依疾病類型劃分
  • 臨床前階段聯盟:依技術類型
  • 與最活躍的公司建立臨床前階段合作夥伴關係(2019-2024年)

第6章 臨床前階段合作付款條件

  • 簡介
  • 臨床前階段付款條件指南
    • 預付款
    • 里程碑付款
    • 特許權使用費
  • 臨床前階段付款條件:交易資料分析
    • 公開資料
    • 調查資料
  • 付款條件分析
    • 臨床前階段交易總額
    • 臨床前階段交易:預付款
    • 臨床前階段交易:里程碑付款
    • 臨床前階段的專利費率

第7章 臨床前階段重大交易

  • 簡介
  • 臨床前階段的主要交易:依交易金額

第8章 臨床前階段交易撮合者:前 25 家公司

  • 簡介
  • 前 25 名最活躍的臨床前交易撮合者

第9章 臨床前階段合作協議清單

  • 簡介
  • 臨床前階段合約交易(2019-2024)

第10章 臨床前階段交易:依開發階段劃分

  • 簡介
  • 臨床前階段的交易

附錄

簡介目錄
Product Code: CP2057

The Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019-2024 report provides a detailed understanding and analysis of how, why and what terms companies enter preclinical stage partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes.

This report provides details of the latest preclinical agreements announced in the healthcare sector.

Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not.

This report contains a comprehensive listing of over 1,800 preclinical stage partnering deals announced since 2019 including financial terms, where available, including links to online deal records of actual preclinical partnering deals as disclosed by the deal parties. In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners.

Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal.

The initial chapters of this report provide an orientation of preclinical stage deal making and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of why companies partner preclinical stage compounds/products.

Chapter 3 provides an overview of preclinical stage deals strategy and deal structure including numerous case studies. Chapter 4 provides an overview of the various payment strategies used in preclinical stage deals.

Chapter 5 provides a review of preclinical stage deal making since 2019. Deals activity is reviewed by year, stage of development at signing, therapeutic area, technology type, as well as most active dealmakers.

Chapter 6 provides a detailed analysis of preclinical stage payment terms including headline, upfront, milestone and royalty rates.

Chapter 7 provides a review of the leading preclinical stage deal by headline value. Each deal title links via Current Agreements deals and alliances database to an online version of the full deal record, and where available, the actual contract document, providing easy access to each deal record on demand.

Chapter 8 provides a comprehensive listing of the top 25 most active preclinical stage dealmaker companies. Each deal title links via Current Agreements deals and alliances database to an online version of the full deal record, and where available, the actual contract document, providing easy access to each deal record on demand.

Chapter 9 provides a comprehensive and detailed review of preclinical stage partnering deals signed and announced since 2019, where a contract document is available in the public domain.

Chapter 10 provides a comprehensive directory of preclinical stage partnering deals since 2019.

The report includes deals announced by hundreds of life science companies including big pharma such as Takeda, AstraZeneca, Eli Lilly, Sanofi, Boehringer Ingelheim, Merck, Roche, Bristol-Myers Squibb, Astellas and many more.

The report also includes numerous tables and figures that illustrate the trends and activities in preclinical stage partnering and deal making since 2019.

In addition, a comprehensive appendix of all preclinical deals since 2019 is provided organized by partnering company A-Z, deal type, therapy focus and technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand.

In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of preclinical stage products and compounds.

Key benefits

Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019-2024 provides the reader with the following key benefits:

  • In-depth understanding of preclinical stage deal trends since 2019
  • Access to headline, upfront, milestone and royalty data
  • Analysis of the structure of preclinical stage agreements with numerous real life case studies
  • Insight into the terms included in a preclinical stage agreement, together with real world clause examples
  • Understand the key deal terms companies have agreed in previous deals
  • Undertake due diligence to assess suitability of your proposed deal terms for partner companies

Report scope

  • Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019-2024 is intended to provide the reader with an in-depth understanding and access to preclinical stage deal trends and structure of deals entered into by leading companies worldwide.

Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019-2024 includes:

  • Trends in preclinical stage dealmaking in the biopharma industry since 2019
  • Analysis of preclinical stage deal structure
  • Access to headline, upfront, milestone and royalty data
  • Case studies of real-life preclinical stage deals
  • Access to over 1,800 preclinical stage deals
  • The leading preclinical stage deals by value since 2019
  • Most active preclinical stage dealmakers since 2019
  • The leading preclinical stage partnering resources

In Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019-2024, the available contracts are listed by:

  • Company A-Z
  • Headline value
  • Stage of development at signing
  • Deal type
  • Specific therapy target
  • Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand.

The Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2019-2024 report provides comprehensive access to available deals and contract documents for over 1,800 preclinical stage deals. Analyzing actual contract agreements allows assessment of the following:

  • What are the precise rights granted or optioned?
  • What is actually granted by the agreement to the partner company?
  • What exclusivity is granted?
  • What is the payment structure for the deal?
  • How are sales and payments audited?
  • What is the deal term?
  • How are the key terms of the agreement defined?
  • How are IPRs handled and owned?
  • Who is responsible for commercialization?
  • Who is responsible for development, supply, and manufacture?
  • How is confidentiality and publication managed?
  • How are disputes to be resolved?
  • Under what conditions can the deal be terminated?
  • What happens when there is a change of ownership?
  • What sublicensing and subcontracting provisions have been agreed?
  • Which boilerplate clauses does the company insist upon?
  • Which boilerplate clauses appear to differ from partner to partner or deal type to deal type?
  • Which jurisdiction does the company insist upon for agreement law?

Table of Contents

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Why do companies partner preclinical stage compounds?

  • 2.1. Introduction
  • 2.2. The role of preclinical stage partnering
    • 2.2.1. In-licensing at preclinical stage
    • 2.2.2. Out-licensing at preclinical stage
  • 2.3. Difference between discovery, preclinical and clinical stage deals
  • 2.4. Reasons for entering into preclinical stage partnering deals
    • 2.4.1. Licensors reasons for entering preclinical stage deals
    • 2.4.2. Licensees reasons for entering preclinical stage deals
  • 2.5. The future of preclinical stage partnering deals

Chapter 3 - Preclinical stage deal strategies and structure

  • 3.1. Introduction
  • 3.2. At what stage do companies partner?
    • 3.2.1. Partnering early in pharmaceutical / biotech
    • 3.2.1.1. Discovery and preclinical stage partnering case studies
    • 3.2.1.1.a. Case study 1
    • 3.2.1.1.b. Case study 2
    • 3.2.1.1.c. Case study 3
    • 3.2.1.1.d. Case study 4
    • 3.2.2. Partnering later in pharmaceutical/biotech
    • 3.2.2.1. Clinical stage partnering case studies
    • 3.2.2.1.a. Case study 5
    • 3.2.2.1.b. Case study 6
    • 3.2.2.1.c. Case study 7
    • 3.2.2.1.d. Case study 8
  • 3.3. Early and later stage partnering - a risk/cost comparison
  • 3.4. What do companies spend on preclinical stage partnering?
  • 3.5. Pure versus multi-component partnering deals
  • 3.6. Pure licensing agreement structure
    • 3.6.1. Example pure preclinical stage licensing agreements
    • 3.6.1.a. Case study 9
    • 3.6.1.b. Case study 10
  • 3.7. Multicomponent preclinical stage partnering agreements
    • 3.7.1. Example multicomponent preclinical stage clauses
    • 3.7.1.a. Case study 11
    • 3.7.1.b. Case study 12

Chapter 4 - Preclinical stage partnering payment strategies

  • 4.1. Introduction
  • 4.2. Preclinical stage payment strategies
  • 4.3. Payment options
    • 4.3.1. Headline values
    • 4.3.2. Upfront payments
    • 4.3.2.1. Conditionality of upfront payments
    • 4.3.3. Loans
    • 4.3.4. Convertible loans
    • 4.3.5. Equity
    • 4.3.6. R&D funding
    • 4.3.7. Licensing fees
    • 4.3.8. Milestone payments
    • 4.3.9. Royalty payments
    • 4.3.9.1. Issues affecting royalty rates
    • 4.3.9.2. Royalties on combination products
    • 4.3.9.2.a. Case study 13
    • 4.3.9.3. Guaranteed minimum/maximum annual payments
    • 4.3.9.4. Royalty stacking
    • 4.3.9.5. Royalties and supply/purchase contracts
    • 4.3.10. Quids
    • 4.3.11. Option payments

Chapter 5 - Trends in preclinical stage deal making

  • 5.1. Introduction
  • 5.2. Preclinical stage partnering over the year
    • 5.2.1. Attributes of preclinical deals
  • 5.3. Preclinical stage partnering by deal type
  • 5.4. Preclinical stage partnering by disease type
  • 5.5. Partnering by preclinical stage technology type
  • 5.6. Preclinical stage partnering by most active company, 2019 - 2024

Chapter 6 - Payment terms for preclinical stage partnering

  • 6.1. Introduction
  • 6.2. Guidelines for preclinical stage payment terms
    • 6.2.1. Upfront payments
    • 6.2.2. Milestone payments
    • 6.2.3. Royalty payments
  • 6.3. Preclinical stage payment terms - deal data analysis
    • 6.3.1. Public data
    • 6.3.2. Survey data
  • 6.4. Payment terms analysis
    • 6.4.1. Preclinical stage headline values
    • 6.4.2. Preclinical stage deal upfront payments
    • 6.4.3. Preclinical stage deal milestone payments
    • 6.4.4. Preclinical stage royalty rates

Chapter 7 - Leading preclinical stage deals

  • 7.1. Introduction
  • 7.2. Top preclinical stage deals by value

Chapter 8 - Top 25 most active preclinical stage dealmakers

  • 8.1. Introduction
  • 8.2. Top 25 most active preclinical stage dealmakers

Chapter 9 - Preclinical stage partnering contracts directory

  • 9.1. Introduction
  • 9.2. Preclinical stage deals with contracts 2019 - 2024

Chapter 10 - Preclinical stage deal making by development stage

  • 10.1. Introduction
  • 10.2. Deals by preclinical stage

Appendices

  • Appendix 1 - Preclinical stage dealmaking by companies A-Z
  • Appendix 2 - Preclinical stage dealmaking by industry sector
  • Appendix 3 - Preclinical stage dealmaking by stage of development
  • Appendix 4 - Preclinical stage dealmaking by therapy area
  • Appendix 5 - Preclinical stage dealmaking by technology type
  • About Biopharma Research Ltd
  • Current Partnering
  • Current Agreements
  • Recent titles from Current Partnering

Table of figures

  • Figure 1: Definition of discovery, preclinical and clinical phases in dealmaking
  • Figure 2: Components of the pure licensing deal structure
  • Figure 3: Payment options for preclinical stage partnering deals
  • Figure 4: Issues affecting royalty rates
  • Figure 5: Preclinical stage partnering frequency 2019 - 2024
  • Figure 6: Preclinical stage partnering by deal type since 2019
  • Figure 7: Preclinical stage partnering by disease type since 2019
  • Figure 8: Preclinical stage partnering by technology type since 2019
  • Figure 9: Top 25 most active preclinical stage dealmakers, 2019 - 2024
  • Figure 10: Review of upfront payments for preclinical stage deals
  • Figure 11: Review of milestone payments for preclinical stage deals
  • Figure 12: Review of royalty payments for preclinical stage deals
  • Figure 13: Preclinical stage deals with a headline value
  • Figure 14: Preclinical stage deals with an upfront value
  • Figure 15: Preclinical stage deals with a milestone value
  • Figure 16: Preclinical stage deals with a royalty rate value
  • Figure 17: Top preclinical stage deals by value since 2019
  • Figure 18: Most active preclinical stage dealmakers 2019 - 2024